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Quality Specialist II

San Jose, CA
Position Role/Tile: Quality Specialist II
Location:  San Jose, CA.

Responsible for supporting development and implementation of a CLIA and GCP- based Quality Management System (QMS) and supporting infrastructure/tools in compliance with CAP/CLIA, FDA Quality System Regulation (QSR) regulations (especially GCP), International Standards Organization (ISO) regulations, and Client corporate requirements. 
Support management and maintenance of training assignments for the site.
Track, monitor and report site training compliance data.
Partner with department managers and trainers to develop/ update training matrices.  Experience in Change management, Supplier qualification, Inspection and CAPA/Client management is an added advantage.
Exposure to internal, external, laboratory, supplier auditing programs as appropriate.  Good to have experience in supporting project-related and QMS documentation using Electronic Document Management System (EDMS).
Support coordination of document and record retention program for the site in alignment with the Client corporate requirements.
Skills  2-4 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations.
Experience focused on quality systems, regulatory affairs/compliance or project management. 
Familiarity with relevant CAP/CLIA, GCP, international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820). 
ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus. 
Understanding of CAP/CLIA and GCP requirements especially.
Keywords Education 
Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677

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